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Philips ForeRunner AED User Manual

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1. 61 PC Card Symbols ueteri e dered decane ees 62 Battery Symbols 64 Dangers Warnings and Cautions 65 General cil cae bk eer 02421401 se e e Re ee ER RS 66 Defibrillatiot e terere EROR Re eR 67 MormIforIn8 c 68 Matntenance serre 222320610221 Rp doa hag EID RR ERES 68 FORERUNNER CHAPTER ONE Introduction his User s Guide provides information for trained operators about using and maintaining the FORERUNNER semi automatic external defibrillator AED This chapter presents general information that you should know before you begin using the FORERUNNER OVERVIEW The FORERUNNER semi automatic defibrillator is lightweight portable and battery powered It performs o Ovorview automatic self tests and displays the results of these tests S on a Status Indicator The FORERUNNER has an LCD Indications screen that displays text prompts patient and event 4 Contraindications information and on some models an electrocardiogram Dangers Warnings and ECG Cautions User s Guide See Appendix B for information about shockable rhythms CHAPTER ONE Introduction When connected with Heartstream defibrillation pads to a patient who is unconscious not breathing and without a pulse the FORERUNNER e prompts you to take specific actions e automatically analyzes the patient s ECG e indicates whether a shoc
2. 1 0 1 2 3 4 5 6 7 8 9 10 Time ms The BITE is the biphasic initiation and termination element and is used to determine whether the load impedance is within an acceptable range The FORERUNNER defibrillator delivers shocks to load impedances from 25 to 180 ohm The duration of each phase of the waveform is dynamically adjusted based on delivered charge in order to compensate for patient variability as follows Load Phase 1 Phase 2 Total Delivered Resistance Duration Duration Tilt Energy 9 ms ms J min max min max 25 1 2 83 5 2 83 5 88 90 130 182 50 1 4 09 5 4 09 5 78 81 130 178 100 196 8 95 5 5 97 5 75 78 131 176 125 1 12 00 5 8 00 5 TT 81 132 178 User s Guide 53 APPENDIX B Specifications Total tilt is defined as the percent voltage decay from the peak voltage of the first phase to the final voltage of the second phase V peak e V Final Total Tilt x 100 peak The interphase delay between phases of the waveform is 400 50 psec HEARTSTREAM CLINICAL SUMMARY AND AMERICAN HEART ASSOCIATION DEFIBRILLATION STATEMENT Overview and Objective Heartstream conducted a study to assess the performance of our 150 J impedance compensating biphasic waveform in the out of hospital setting on 100 consecutive victims of sudden cardiac arrest treated by a wide range of first responders both traditional and non traditional AEDs incorporating
3. CHAPTER TWO Putting the FORERUNNER into Service BIT Interactive Tests Description and Outcome of the Tests Speaker Microphone An audible test of the speaker occurs when the screen message appears You should hear two beeps during a successful test LEDs Observe the two LEDs to verify that they both illuminate A Connector socket LED B Shock button LED Contrast Buttons v 2 Press each contrast button when the screen prompt appears Beeps and a screen message verify the test LCD Screen Observe the test pattern on the LCD screen to verify operation and adjust the contrast as needed A Contrast buttons Press 4 to increase contrast Press v to decrease contrast Shock Button e Press the shock button when the screen prompt appears A beep and screen message verify the test Pressing the shock button will not deliver a shock during the BIT interactive test Manual Override Button Model EM only If the FORERUNNER is equipped with a manual override but ton slide the cover to expose the button Press the manual override button when prompted A beep and a screen message verify the test On Off oN OA Press On Off when the screen prompt appears A beep and screen message verify that the interactive portion of the BIT is complete The FORERUNNER turns off Observe the Status Indicator to determine if the FORERUNNER passed the BIT User s Guide
4. ELAPSED TIME 4 08 SHOCKS DELIVERED 4 FIRST SHOCKS AT 00 26 01 35 03 02 O User s Guide 35 CHAPTER FIVE Event Review Storage and Retrieval Full Event Review appears on several screens in a sequence The highlight bar appears on the lower line Press the contrast down button to display the next screen The data stored on the PC data card is overwritten by the next new use of the FORERUNNER in an emergency event The data can be erased from the card by using the optional accessory software 36 FORERUNNER 9 FoRERUNNER Models Using the FoRERUNNER Setup Card 9 Configuring Setup Options QD Training options APPENDIX A FORERUNNER Options card models let you customize the FORERUNNER to match your program s protocol This Appendix describes FORERUNNER options F ORERUNNER models setup options and PC data FORERUNNER MODELS The three available models are the FORERUNNER Model S FORERUNNER Model E and FORERUNNER Model EM The FORERUNNER Model S is the standard model The FORERUNNER Model S does not display an ECG trace or heart rate The FORERUNNER Model E enhanced adds the option to display heart rate and an ECG trace You select the display options using the FORERUNNER Setup card before you put the FORERUNNER into service The FORERUNNER Model EM enhanced manual always displays heart rate and an ECG trace and has the manual override button User s Guide 37 APPENDI
5. A WARNING The BIT and periodic self tests are designed to assess the FORERUNNER S readiness for use However no degree of testing can assure performance or detect abuse damage or a defect which occurs after the last BIT or self test is completed CHAPTER TWO Putting the FORERUNNER into Service STATUS INDICATOR AND AUTOMATIC SELF TESTS The Status Indicator displays the results of the last complete BIT or periodic self test The BIT and self tests perform comprehensive checks of the internal electronics of the FORERUNNER They do not however eliminate the need for FORERUNNER maintenance as specified in this User s Guide The Status Indicator has three operating conditions Status Indicator Condition Action Alternates these two shapes The FORERUNNER passed the The FORERUNNER is ready for BIT or the last periodic auto use matic self test Displays a flashing red X accompanied by a chirping sound The FORERUNNER requires e Remove and reinstall the attention FORERUNNER use is battery A screen message not recommended because the will tell you if the standby FORERUNNER may not per temperature range has been form properly A flashing red exceeded X can indicate Check to assure that the alow battery FORERUNNER is being stored in the recommended storage of the standby temperature range FORERUNNER outside see Appendix B of the recommended standby temperature range If there is no
6. IN CAUTION The FoRERUNNER manual override button is intended for use only by qualified operators who have been trained in rhythm recognition and treat ment through manual charging and delivery of defibrillation shocks Possible ECG Misinterpretation A WARNING Do not place defibrillation pads in the anterior posterior position A shock or no shock decision may be inappropriately advised The FoRERUNNER requires that the defibrillation pads be placed in the anterior anterior position A WARNING Some very low amplitude or low frequency rhythms may not be interpreted as shockable VF rhythms Also some VT rhythms may not be inter preted as shockable rhythms IN WARNING Handling or transporting the patient during ECG analysis can cause incorrect or delayed diagnosis especially if very low amplitude or low fre User s Guide 67 APPENDIX D Dangers Warnings and Cautions quency rhythms are present Following Shock Advised prompts patient move ment and vibration if present must be minimized for at least 15 seconds to allow reconfirmation of ECG analysis before delivering a shock This reconfirmation of ECG analysis may result in an appropriate reversal of a Shock Advised prompt A WARNING In patients with cardiac pacemakers the FORERUNNER may have reduced sensitivity and not detect all shockable rhythms Possible Burns and Ineffective Energy A WARNING Do not allow defibrillation pads to touch each other or to touch
7. Device History Display Screen Display Options USES The first number is the cumulative number of new uses during the FORERUNNER lifetime The cumulative time in minutes of all FORERUNNER uses in which defibrillation pads were con nected to the patient during emergency events is indicated by the second number SHOCKS Cumulative number of shocks delivered by the FORERUNNER in its lifetime TRAINING The first number is the cumulative number of times the Train ing card was inserted and used during the FORERUNNER S life time The cumulative training time in minutes is indicated by the second number TESTS Cumulative number of tests that have been performed during the FORERUNNER s lifetime A Number of daily automatic self tests B Number of weekly automatic self tests C Number of monthly automatic self tests D Number of Battery Insertion tests User s Guide 43 APPENDIX A FORERUNNER Options TRAINING OPTIONS Heartstream offers an optional FORERUNNER Training card and user s guide The FORERUNNER Training card includes simulated scripts that guide responders through several emergency events A training card must always be installed in the FORERUNNER when using it for training or demonstration purposes When the training or demonstrations are complete remove the training card to return the FORERUNNER to service and prevent battery depletion 44 FORERUNNER Q Technical Spe
8. FORERUNNER as soon as the status indicator changes to the alternating hourglass A screen prompt alerts you to a low battery condition The FORERUNNER battery is low Battery failure may be imminent Replace the battery as soon as possible A screen prompt instructs you to replace the battery immedi ately The Status Indicator dis plays a flashing red x No power remains to continue operating the FORERUNNER If you do not replace the battery the FORERUNNER turns off Replace the battery immedi ately NOTE Perform CPR as necessary any time there is a delay in FORERUNNER use User s Guide 21 CHAPTER THREE Using the FORERUNNER Error Condition Possible Cause Corrective Action Voice and screen prompts instruct you to attach the defibrillation pads and to plug in the connector The defibrillation pads are not properly applied to the patient are not connected to the FORERUNNER are touching each other e Ensure that the defibrilla tion pads connector is com pletely inserted in the connector socket e Check the defibrillation pads on the patient and ensure that the pads adhere completely to the skin e lfnecessary wipe moisture from the patient s chest and shave or clip excessive chest hair Replace the defibrillation pads if the prompt contin ues Voice and screen prompts instruct you to check the defibrillation pads or to press the def
9. BIT fails install a new battery and repeat the BIT If the BIT passes the ForeRunner is ready for use If the BIT fails remove the FORERUNNER from service and contact Customer Service User s Guide 11 CHAPTER Two Putting the FORERUNNER into Service 12 FORERUNNER e Preparation Analysis and Monitoring 17 Semi automatic Delivery of Defibrillation Shock Manual Delivery of Defibrillation Shock Error Conditions Possible Causes and Corrective Actions 24 Continued Use CHAPTER THREE Using the FORERUNNER his chapter describes how to use the FORERUNNER in an emergency The FORERUNNER automatically provides appropriate voice and display prompts to guide the operator through a variety of device and patient conditions The steps for using the FORERUNNER in the semi automatic mode are explained first Use of the optional manual override button Model EM is described later in this chapter Finally this chapter describes corrective actions in cases when warnings or errors occur User s Guide 13 CHAPTER THREE Using the FORERUNNER PREPARATION S Press the On Off button s2 to turn on the FORERUNNER Fol low the instructions provided by the FoRERUNNER voice and Screen prompts Remove clothing from the patient s chest If necessary wipe moisture from the patient s chest and clip or shave excessive chest hair o Open the package containing the defibrillation pads with
10. Self Tests 10 Using the FORERUNNER 13 PreparatfiOn ch xo 14 Analysis and Moritoring 16 Semi automatic Delivery of Defibrillation Shock 17 Pause for C R cis derenin Eire dete woe ak del vested etg 18 Manual Delivery of Defibrillation Shock 19 Error Conditions Possible Causes and Corrective Actions 21 Continued se 24 Maintaining the FORERUNNER 25 Self Tests and FORERUNNER Maintenance 25 Maintenance Schedule 27 Cea ios dodi ee dtu yee th oe th eee opt eto eee 29 Automated Defibrillators Operator s Check List 30 Event Review Storage and Retrieval 31 Installing the Optional PC Data Card 31 Event Review cesses 33 User s Guide 1V TABLE OF CONTENTS FORERUNNER Options 37 FORERUNNER Models 37 Using the FORERUNNER Setup Card 38 Configuring Setup Options 39 Training Options 44 Specifications 45 Technical Specifications 46 Heartstream Clinical Summary and American Heart Associa tion Defibrillation Statement 55 Service and Replaceable Parts 57 Glossary of Symbols 59 FORERUNNER Symbols 60 Screen Symbols
11. Sensitivity gt 90 96 Shockable Rhythm VT 100 FORERUNNER meets the AAMI DF39 requirement and AHA recommendation of Sensitivity 75 96 Non shockable rhythm Normal 300 FORERUNNER meets the AAMI DF39 sinus rhythms requirement of Specificity gt 95 and AHA recommendation of Specificity 99 96 Non shockable rhythm Asystole 100 FORERUNNER meets the AAMI DF39 requirement and AHA recommendation of Specificity gt 95 96 Non shockable rhythm all other 450 FORERUNNER meets the AAMI DF39 requirement and AHA recommendation of Specificity gt 95 96 From Heartstream ECG rhythm databases Automatic External Defibrillators for Public Access Use Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance Incorporation New Waveforms and Enhancing Safety American Heart Association AHA AED Task Force Subcommittee on Safety amp Efficacy draft 3 18 96 Table 2 User s Guide 49 APPENDIX B Specifications ECG Display Available only on Model E and Model EM Category Specification Monitored Lead ECG information is acquired through defibrillation pads in anterior anterior Lead II placement Display Range Screen Differential 2 mV full scale nominal High resolution LCD with backlight Screen Dimensions 2 8 inches wide x 2 3 inches high 70 mm x 58 mm Sweep Speed 23 mm sec nominal Normal Sinus Rhythm Frequency Respon
12. and treatment through manual charging and delivery of defibrillation shocks The FORERUNNER Model EM includes a manual override but ton to allow qualified personnel the option to deliver a shock regardless of the FORERUNNER s analysis of ECG data You can use manual override after connecting the defibrilla tion pads The manual override button does not function if the FORERUNNER Model EM analysis already indicates a shock is appropriate e defibrillation pads are not attached User s Guide CHAPTER THREE Using the FORERUNNER A CAUTION The LCD screen is intended only for basic ECG rhythm identification The frequency response of the monitor screen is not intended to provide the resolution required for diagnostic and ST segment interpretation DISARM gt Ay MANUAL OVERRIDE To use the manual override button 1 Slide the cover away from the manual override button 2 Press the manual override button once to select the manual override mode 3 Press manual override again within five seconds to charge the FORERUNNER Model EM so you can deliver a shock The FORERUNNER is ready to deliver a shock when the shock button illuminates and flashes and you hear a steady tone 4 Press the shock button to deliver a shock If you fail to press the manual override button N a second time within 5 seconds the FORERUNNER returns to semiauto matic operation it analyzes the patien
13. display a Summary or Full Event Review at any time unless a FORERUNNER Training card is installed a FORERUNNER Setup card is installed User s Guide 33 CHAPTER FIVE Event Review Storage and Retrieval To display the Event Review 1 Turn off the FORERUNNER 2 Press both contrast buttons v while you press the On Off button s on the FORERUNNER 34 FORERUNNER CHAPTER FIVE Event Review Storage and Retrieval Summary Event Review If a PC data card was not installed during the last emergency event you can view Summary information on the FORERUNNER screen Summary Event Review includes e the elapsed time that the FORERUNNER was on during the emergency event e the number of shocks delivered You can display a Summary Event Review for the last emergency event until it is overwritten by the next new use of the FORERUNNER in an emergency event Full Event Review PC data card options add information storage and retrieval capabilities to the Event Review See Appendix B for information about PC data card capabilities If a PC data card is installed the FORERUNNER automatically stores Full Event Review information on the card Full Event Review information includes e the elapsed time that the FORERUNNER was on during the emergency event e the number of shocks delivered e the times of the first shocks delivered e FORERUNNER related events and associated times EVENT REVIEW PRESS OFF TO QUIT
14. mode 17 not advised 16 shock button testing and verification 9 shockable rhythms 48 and cardiac pacemakers 16 shocks between CPR pauses 41 speaker volume adjusting 40 speakers testing 9 specifications battery 50 controls and indicators 51 defibrillation pads 51 defibrillator 47 defibrillator shock 53 ECG display 50 environmental 46 patient analysis system 48 49 PC data cards training and setup cards 52 physical 46 waveform 53 standby temperature 7 26 46 61 Status Indicator conditions and corrective actions 10 26 stored information about an emergency 33 34 Summary Event Review 35 symbols glossary of 60 User s Guide 71 T technical specifications 46 technical support 57 temperature standby 7 26 46 61 time elapsed 18 35 of first shocks 35 on PC data cards 52 remaining in pause for CPR 18 timeout for CPR 18 duration 41 interrupting 19 Training card 44 affecting Status Indicator 10 INDEX U use appropriate symptoms 3 elapsed time of 35 number of shocks delivered 34 with pacemakers 16 using the data card 31 V voice prompts setup options 40 volume changing 40 W warnings dangers and cautions 65 waveform 47 specifications 53 when no shock is advised 16 X X in Status Indicator meaning 10 72 FORERUNNER 73 FORERUNNER P N 010136 0010 74 FORERUNNER
15. of the optional PC data card If the PC data card is installed the BIT verifies that the card is compatible with the FORERUNNER and that the FORERUNNER is able to communicate with the card The FORERUNNER screen indicates whether the card has data from a previous event stored on it or is cleared of data The FORERUNNER screen also indicates if an optional PC data card is not installed if the card 1s incompatible with the FORERUNNER or if the FORERUNNER system is unable to communicate with the card If you get a screen prompt that alerts you that there is a data card error remove the card Ensure that the card is a Heartstream PC data card and it was installed correctly If it is a Heartstream PC data card and was installed correctly remove the card and contact Customer Service for a new card Interactive Tests in the BIT When the automatic part of the BIT and PC data card verification are complete the BIT begins interactive tests These tests allow you to verify the correct operation of the screen buttons LEDs and speaker on the FORERUNNER The FORERUNNER screen guides you through these tests Observe each test follow the prompts as indicated and note any discrepancies If any portion of the BIT fails replace the battery with a new battery and repeat the BIT If any portion of the second BIT fails remove the FORERUNNER from service and contact Customer Service Descriptions of the interactive tests follow FORERUNNER
16. on a card can be reviewed and reports can be generated using a personal computer Optional training and setup cards allow the FORERUNNER to perform additional training and setup functions INDICATIONS The FORERUNNER in semi automatic or manual override mode is indicated for use on victims of sudden cardiac arrest on whom an apparent lack of circulation is indicated by e Unconsciousness e Absence of breathing e Absence of detectable pulse The FORERUNNER is for use by emergency care personnel specifically trained in the operation of the FORERUNNER and qualified by training in advanced cardiac life support in basic life support or in other physician authorized emergency medical response The FORERUNNER must be used by or on the order of a physician The FORERUNNER was not designed or tested to interpret pediatric arrhythmias or administer energy at pediatric joule settings For children older than 8 years the American Heart Association recommends that standard operating procedures for AEDs be followed American Heart Association Textbook of Advanced Cardiac Life Support Dallas Tex AHA 1994 Refer to the chapter on event review storage and retrieval for detailed information about using PC data cards and other options User s Guide CHAPTER ONE Introduction CONTRAINDICATIONS The FORERUNNER is contraindicated for use on patients exhibiting any one of the following e Consciousness e Presence of breathing e P
17. or other fluids Do not allow fluids to enter the FORERUNNER Avoid spilling any fluids on the FORERUNNER or accessories Spilling fluids into the FORERUNNER may damage it or present a fire or shock hazard Do not autoclave or gas sterilize the FORERUNNER or accessories A DANGER The FoRERUNNER has not been evaluated or approved for use in haz ardous locations as defined in the National Electrical Code standard Articles 500 503 In compliance with the IEC classification section 5 5 the ForeRunner is not to be used in the presence of flammable substance air mixtures Possible Improper Device Performance A WARNING Use only Heartstream disposable defibrillation pads batteries and other accessories supplied by Heartstream or its authorized distributors Substitution of non Heartstream accessories may cause the device to perform improperly A CAUTION Follow all defibrillation pad labeling instructions Use defibrillation pads prior to their expiration date Discard defibrillation pads after use Do not reuse defibrillation pads A CAUTION Follow all battery labeling instructions Install the battery prior to tne date noted on the battery A WARNING The BIT and periodic self tests are designed to assess the FORERUNNER S readiness for use However no degree of testing can assure perfor mance or detect abuse damage or a defect which occurs after the last BIT or self test is completed A CAUTION Although the FoRERUNNER is desig
18. the FORERUNNER automati cally resumes analyzing the ECG data to determine if the shock was effective The FORERUNNER continues to provide voice and display prompts that guide you through additional shock sequences if appropriate The FORERUNNER also dis plays the number of shocks that have been delivered If a series of unsuccessful shocks has occurred the FORERUNNER will automatically pause for CPR see Pause for CPR CS Pause for CPR below PAUSE FOR CPR The FORERUNNER automatically pauses to allow time to administer CPR with associated verbal and screen prompts at the beginning of the pause period The FORERUNNER sup presses analysis and voice prompts during the pause to allow ANN PAUSED uninterrupted patient care The heart rate display also is L 1 06 3 ATTEND TO PATIENT blank during the pause period During a pause for CPR the screen displays a bar that fills as the pause time elapses A Bar indicates time remaining in the pause for CPR B Elapsed time since the FORERUNNER was turned on and the number of shocks delivered The FORERUNNER can be programmed with a setup card see Appendix A for instructions to provide two independent pause periods a Consecutive Shock CS pause and a NO Shock Advised NSA pause CS Pause The FORERUNNER can be set up to pause after a series of con secutive unsuccessful shocks Typically protocols advise up to three consecutive shocks followed by a one minute
19. to abuse If cracks or and signs of damage damage are noted remove the After each use FORERUNNER from service and contact Heartstream Cus tomer Service PC data card Remove the used PC data card and replace it with a spare according to instructions found in Chapter 5 Event Review Storage and Retrieval Apply the patient ID label to the PC data card and deliver the card to appropriate per sonnel according to local guidelines and medical proto col Ensure the FORERUNNER Clean the FORERUNNER if exterior and connector socket needed See the section later are free of dirt or contamina in this chapter titled Cleaning lung Perform the BIT according to Status Indicator instructions in Chapter 2 Calibration is unnecessary as the FoRERUNNER automatically performs daily self tests and correct operation is verified during the BIT The FoRERUNNER does not require manual verification of energy delivery because monthly automatic self tests verify the waveform delivery system The FoRERUNNER has no user serviceable parts and Heartstream is the sole repair facility for the unit As a result we do not publish Service Maintenance and Repair Manuals for technical professionals A CAUTION Improper maintenance can cause the FORERUNNER not to function Maintain the ForeRunner only as described in this User s Guide or as designated by your program s medical director A CAUTION Electrical shock hazard Dangerous high vo
20. 150 J impedance compensating biphasic waveforms were placed into service of 34 EMS systems Data were obtained from the AED PC data card recording system The first endpoint was to determine the effectiveness of this waveform at terminating VF Defibrillation was defined using the standard definition of conversion to an organized rhythm or to asystole The second endpoint was to determine whether or not the use of such an AED culminated in an organized rhythm at the time of patient transfer to an advanced life support ALS team or 54 FORERUNNER APPENDIX B Specifications emergency department ED The third endpoint was to assess the efficiency of the human factors design of the AED by measuring user time intervals Results Thirty four sites provided data on 286 consecutive AED uses 100 from SCA victims with VF as their initial rhythm upon attachment of the AED All 286 patients were correctly identified by the AED as requiring a shock 100 96 sensitivity to the 100 VF patients or not 100 specificity to the 186 patients not presenting in VF The time from emergency call to first shock delivery averaged 9 1 7 3 minutes A single 150 J biphasic shock defibrillated the initial VF episode in 86 of patients For all 450 episodes of VF in these 100 patients an average of 86 2496 of VF episodes was terminated with a single biphasic shock Of the 449 VF episodes that received up to three shocks 97 1196 were termina
21. MATED DEFIBRILLATORS OPERATOR S CHECK LIST FORERUNNER Model No Serial No FORERUNNER Location or vehicle ID Inspect the FORERUNNER at frequencies specified in this chapter or as designated by your medical director Indicate whether all requirements have been met Note any corrective action taken Sign at the bottom of the form Date Frequency Interval FORERUNNER Unit Clean no dirt or contamina tion no damage present Supplies Available a Two sets defibrillation pads sealed within expiration date undamaged b Ancillary supplies Hand towel scissors razor c Spare unopened battery within Install Before date d PC data card undamaged with spares Status Indicator a Self test okay verify by noting Status Indicator Inspected by Remarks Problems Corrective Actions Applicable only if unit uses this option 30 FORERUNNER e Installing the Optional PC Data Card Event Review CHAPTER FIVE Event Review Storage and Retrieval he FORERUNNER stores data in its own internal memory and on optional PC data cards supplied by Heartstream Data stored in the FORERUNNER internal memory and the PC data card can be displayed on the FORERUNNER screen Heartstream also provides CodeRunner software to review archive and report the information stored on the PC data cards INSTALLING THE OPTIONAL PC DATA CARD If you use the optional PC data car
22. R APPENDIX B Specifications Defibrillator Category Specification Waveform Truncated Exponential Biphasic Waveform parameters are adjusted as a function of patient defibrillation impedance Energy Energy Selection Single Energy a nominal of 150 Joules minimum of 130 Joules delivered to a 50 ohm load Charge Control Under control of the Patient Analysis System for semi auto matic operation The manual override button allows manual charge control FORERUNNER Model EM only Charge Time from Shock Advised Shock to Shock Cycle Time Typically less than 10 seconds Charge time increases at the end of battery life as well as at temperatures below 10 C Typically less than 20 seconds including analysis time in semi automatic mode Charge Complete Indication FORERUNNER is armed when shock button is flashing and armed tone is activated Shock Discharge Control Shock is delivered by a single shock button Disarm Semi Automatic Operation Once the FORERUNNER is charged it will disarm under any of the following conditions ano shock decision is reached the FORERUNNER On Off button is pressed and the FORERUNNER is turned off the defibrillation pads are removed from the patient or the pads connector is disconnected from the FORERUNNER Disarm Manual Operation Once the FORERUNNER is charged it will disarm under any of the following conditions 30 sec
23. R must complete a BIT before being put into service A message will also be displayed if the FORERUNNER has been stored outside of the recommended standby temperature range since the last BIT was completed Storing the FORERUNNER outside of the standby temperature and environmental specifications noted in Appendix B will shorten battery life and prevent the FORERUNNER from performing self tests The FORERUNNER performs a complete BIT when you install a battery unless QVO Inanemergency you press the On Off button s to stop the BIT e Defibrillation pads are attached to a patient indicating that the FORERUNNER is in use e Less than five minutes have passed since the last use indicating that it is likely the FORERUNNER is still in use e The FORERUNNER detects that a Training card or a Setup card is installed e The battery is completely depleted e The FORERUNNER is outside of the operating temperature specification If any portion of the BIT fails replace the battery with a new battery and repeat the BIT If any portion of the second BIT fails remove the FORERUNNER from service and contact Heartstream Customer Service The Status Indicator tells you if the FORERUNNER passed the BIT See the section later in this chapter titled Status Indicator and Automatic Self Tests User s Guide CHAPTER TWO Putting the FORERUNNER into Service PC Data Card Verification The BIT automatically checks for the presence
24. THE FORERUNNER A ON OFF Initiates voice and screen prompts Press again to turn off STATUS INDICATOR Shows when the FORERUNNER is ready to use based on automatic self tests BATTERY LATCH Slide to eject the battery MICROPHONE Located behind the battery latch Records voice information when optional PC voice data card is installed OPTIONAL MANUAL OVER RIDE BUTTON Available on Model EM only Permits qualified users to manually charge the FORERUNNER and deliver a shock CONTRAST BUTTONS Adjust LCD screen con trast and are used to control other functions DISPOSABLE RECYCLABLE BATTERY Provides power for the FORERUNNER OPTIONAL PC DATA CARD Stores ECG and event data An optional card can also store voice data Separate cards provide setup and training options LCD SCREEN Displays text prompts and patient event information ECG and heart rate can be dis played on Models E and EM SHocK BUTTON K Controls shock delivery The button flashes when the FORERUNNER is ready L to deliver a shock DEFIBRILLATION PAD PLACEMENT ILLUSTRATION CONNECTOR SOCKET Insert the defibrillation pads connector into the connector socket The LED flashes to indicate the socket location The LED is covered when the defibrillation pad connector is properly inserted in the socket J SPEAKER Provides audi ble instructions and information about the FORERUNNER and the pati
25. X A FORERUNNER Options USING THE FORERUNNER SETUP CARD Before you put a FORERUNNER into service you should configure options to match your program s protocol using the FORERUNNER Setup card Failure to configure settings correctly may adversely affect use of the FORERUNNER To configure options install the FORERUNNER Setup card 1 Remove the battery 2 Insert the Setup card in the slot with the arrow label facing up 3 Push the card in until it is flush with the slot Do not force the card into the slot If the card is difficult to insert remove it and verify that the arrow label faces up 4 Replace the battery When you install the Setup card the FORERUNNER automatically turns on with the setup options displayed on the screen No BIT takes place 36 FORERUNNER APPENDIX A FORERUNNER Options While the Setup card is installed e the On Off button O is disabled e the FORERUNNER is operable only for setup functions e the Status Indicator shows a solid red X e if no buttons are pressed for five minutes the FORERUNNER chirps to prompt you to continue the setup or remove the Setup card At the completion of the setup remove the Setup card replace the battery and perform the BIT to put the FORERUNNER into service CONFIGURING SETUP OPTIONS Setup options are described below Press the contrast down button y to move between menu items Press the contrast up button 4 to choose or change an
26. attached cable and connector Pull off the protective backing from the defibrillation pads Ensure the pads are free from obvi ous signs of damage and that the gel has not dried out If the pads are damaged or the gel has dried out use a new set of pads Defibrillation pad placement is essential to successful defibrilla tion Place one defibrillation pad just below the patient s right clavicle Place the second defibrillation pad over the ribs on the patient s side in line with the axilla armpit and below the patient s left breast Refer to the diagram on the back of the defibrillation pads Insert the defibrillation pads connector in the connector socket located by the flashing light 14 FORERUNNER CHAPTER THREE Using the FORERUNNER A WARNING Use only Heartstream disposable defibrillation pads batteries and other accessories supplied by Heartstream or its authorized distributors Substitution of non Heartstream accessories may cause the device to perform improperly A CAUTION Follow all defibrillation pad labeling instructions Use defibrillation pads prior to expiration date Discard defibrillation pads after use Do not reuse defibrillation pads A WARNING Do not place defibrillation pads in the anterior posterior position A shock or no shock decision may be inappropriately advised The FORERUNNER requires that the defibrillation pads be placed in the anterior anterior position IN WARNING Do not allow de
27. cifications Heartstream Clinical Summary and American Heart Association Defibrillation Statement Service and Replaceable Parts APPENDIX B Specifications his appendix presents technical specifications waveform specifications a clinical summary and information about service and replaceable parts User s Guide 45 APPENDIX B Specifications TECHNICAL SPECIFICATIONS Physical Category Specification Size 2 53 inches high x 8 75 inches wide x 8 0 inches deep 64 mm x 223 mm x 203 mm Weight Approximately 2 kg 4 4 Ibs with battery installed Environmental Category Specification Operating Temperature 0 to 50 C 32 to 122 F 0 to 95 Relative Humidity non Humidity condensing Standby Temperature Humidity 10 to 43 C 50 to 109 F 096 to 75 Relative Humidity non condensing FORERUNNER with battery installed stored with defibrillation pads Altitude 500 to 15 000 feet per MIL 810E 500 3 Procedure II Shock Drop Abuse Tolerance MIL STD 810E 516 4 Procedure IV 1 meter any edge corner or surface Vibration MIL STD 810E 514 4 17 Sealing IEC 529 class IP54 Splash Proof Dust Protected ESD IEC 801 2 Severity Level 4 EMI Radiated CISPR11 Group 1 Level B EMI Immunity Transportation Environment IEC 801 3 Level 2 RTCA DO 160C Environmental conditions and test procedures for airborne equipment 46 FORERUNNE
28. commendation 56 FORERUNNER APPENDIX B Specifications SERVICE AND REPLACEABLE PARTS There are no user serviceable components in the FORERUNNER Contact Customer Service about returning a FORERUNNER that has suspected operating problems Calibration is unnecessary as the FORERUNNER automatically performs daily self tests and correct operation is verified during the BIT The FORERUNNER does not require manual verification of energy delivery because monthly automatic self tests verify the waveform delivery system Asa result we do not publish Service Maintenance and Repair Manuals for technical professionals Items that can be ordered routinely include PC data cards and patient identification labels FORERUNNER Training card FORERUNNER Setup card FORERUNNER battery pack FORERUNNER package containing defibrillation pads cable and connector FORERUNNER carrying case e Mannequin adaptors e FORERUNNER accessory software Contact Customer Service or your local distributor for ordering information N CAUTION Electrical shock hazard Dangerous high voltages and currents are present Do not open unit remove covers or attempt repair There are no user serviceable components in the FORERUNNER Refer servicing to qualified service personnel User s Guide 57 APPENDIX B Specifications 58 FORERUNNER ForeRunner Symbols e Screen Symbols Pc card symbols o Battery Symbols APPENDIX C Gl
29. d the FORERUNNER can store and retrieve more detailed information about its own status and about emergency events If you choose to use a PC data card it must be installed before you put the FORERUNNER into service User s Guide 31 CHAPTER FIVE Event Review Storage and Retrieval Use only Heartstream PC data cards Other data cards are not compatible with the FORERUNNER To install the optional PC data card PULL TAB 1 Remove the battery 2 Make sure the card is clean dry and free of old patient identification labels 3 Insert the PC data card in the slot with the arrow label facing up 4 Push the card in until it is flush with the slot Do not force the card into the slot If the card is hard to insert remove it and verify that the arrow label faces up 5 Replace the battery and perform the BIT 32 FORERUNNER CHAPTER FIVE Event Review Storage and Retrieval After each FORERUNNER use replace the PC data card 1 Remove the battery Pull the PC data card out by its pull tab Apply the patient ID label to the PC data card and deliver the card to the appropriate personnel Insert a new PC data card Replace the battery and perform the BIT EVENT REVIEW The FORERUNNER automatically stores information about a use of the FORERUNNER in an emergency event even if a PC data card is not used This information can be displayed on the FORERUNNER screen How to Display Event Review You can
30. efibrillation pads to the patient 14 artifact 16 23 67 attaching pads 14 B battery conditions and Status Indicator 10 21 dead or depleted 11 21 insertion 6 maintenance 25 27 position during cleaning 29 specifications 50 symbols 64 testing 25 Battery Insertion Test BIT 7 how to interrupt 7 interactive tests 8 biphasic waveform 47 53 BIT See Battery Insertion Test burn hazard 68 C cautions warnings and dangers 65 charge release when no shock delivered 17 chirping due to low battery or self test failure 10 26 due to setup card 39 cleaning instructions and precautions 29 clock on PC data cards 52 configurable options 40 connecting the defibrillation pads 14 contamination 28 continued use 24 contraindications 3 contrast buttons used in Event Review 36 contrast adjusting 9 controls and indicators 51 corrective actions for error conditions 21 CPR 18 duration of pause 41 interrupting to analyze ECG 19 number of shocks between pauses 41 pause for 18 protocol 40 D damage checks for mechanical 27 to connector socket 27 danger warnings and cautions 65 data card compatibility 32 installation 32 reading 31 removing 32 verification during BIT 8 defibrillation pads applied improperly 22 applying 14 expiration date 15 27 66 maintaining 27 placed improperly 23 specifications 51 defibrillator shock specification 53 defibrillator specifications 47 depleted battery and Statu
31. ent s status M DEFIBRILLATION PADS Disposable and self adhesive Defibrillation pads include attached cable and connector FORERUNNER SEMI AUTOMATIC MODE Quick REFERENCE FORERUNNER semi automatic defibrillator User s Guide For Model S Model E Model EM Va ETT Heartstream the Heartstream logo FORERUNNER the FORE RUNNER logo and CODERUNNER are either registered trade marks or trademarks of Hewlett Packard Company in the United States and or other countries The FORERUNNER semi automatic defibrillator is sold in some markets as the Laerdal Heartstart FR Laerdal and Heartstart are registered trademarks of Laerdal Medical Corporation FORERUNNER as used in this document refers to either the HP Heartstream FORERUNNER semi automatic defibrillator or the Laerdal Heartstart FR Specifications are subject to change without notice Published in the U S A A CAUTION Federal law USA restricts this device to sale by or on the order of a physician il FORERUNNER TABLE OF CONTENTS Introduction 1 OV6EVIOW oh Siete oth thd die eee oA ei deie tragic ds 1 Indications 0 0 eee eee eee n eee 3 Contraindications od eye b4 x can e ed Rd dg uc den 4 Dangers Warnings and Cautions 4 Putting the FORERUNNER into Service 5 How to Put the FORERUNNER into Service 5 Battery Installation and the Battery Insertion Test 6 Status Indicator and Automatic
32. ery Insertion and changing the factory settings Test BIT as described on the following pages see Appendix A For information about installing and using PC data 2 Put the FORERUNNER in an accessible area with the cards see the chapter on event Status Indicator easily visible See Appendix B for review storage and retrieval g the environmental standby storage specifications CAUTION Follow all battery 3 Observe the Status Indicator daily and as described labeling instructions Install the R battery prior to the date noted on later in this chapter the battery BATTERY INSTALLATION AND THE BATTERY INSERTION TEST When you are ready to put the FORERUNNER into service install the battery as shown below Snap the battery into place using a single motion and firm pressure The battery should click into place when it is properly inserted 6 FORERUNNER CHAPTER TWO Putting the FORERUNNER into Service The Battery Insertion Test BIT At the time you install a battery the FORERUNNER automatically performs a comprehensive self test called the Battery Insertion Test BIT The BIT has two parts an automatic self test followed by an interactive test During the automatic part of the BIT the screen displays information about the progress of the self test No user interaction is required during the automatic part of the BIT If the screen displays a message that a previous self test has failed the FORERUNNE
33. es voice and screen prompts that advise you to take action such as DO NOT TOUCH THE PATIENT until the ECG interference stops If No Shock is Advised Voice and screen prompts inform you when the FORERUNNER determines that no shock is advised The FORERUNNER contin ues to monitor ECG data while you provide appropriate care to the patient While the FORERUNNER is monitoring the patient voice prompts are suppressed While monitoring if the FORERUNNER detects that the patient s ECG changes to a potentially shockable rhythm or if the FORERUNNER is not able to analyze the rhythm because of inter ference it will automatically shift to analyzing mode and give corresponding voice and screen prompts to advise you to respond appropriately If No Shock is Advised and the No Shock Advised NSA Pause for CPR is Programmed Voice and screen prompts inform you when the FORERUNNER determines that no shock is advised The FORERUNNER then pauses to allow time to administer CPR if needed without interruption See Pause for CPR later in this chapter for more details At the end of the pause for CPR the FORERUNNER returns to monitoring the patient as described above 16 FORERUNNER CHAPTER THREE Using the FORERUNNER SEMI AUTOMATIC DELIVERY OF DEFIBRILLATION SHOCK A WARNING Defibrillation current can cause operator or bystander injury Do not touch the patient during defibrillation Do not touch equipment connected to
34. fibrillation pads if they become damaged during use A WARNING Use of damaged equipment or accessories may cause the device to perform improperly and or patient or user injury User s Guide 15 A WARNING Handling or transporting the patient during ECG analysis can cause incorrect or delayed diagnosis Following Shock Advised prompts patient movement and vibration if present must be minimized for at least 15 seconds to allow reconfirmation of ECG analysis before delivering a shock A WARNING In patients with cardiac pacemakers the FORERUNNER may have reduced sensitivity and not detect all shockable rhythms A WARNING Radio frequency RF interference from RF devices such as cellular phones and two way radios may cause improper FORERUNNER operation In accordance with IEC standard 801 3 a distance of 2 meters 6 feet between RF devices and the FORERUNNER is recommended A WARNING CPR rates above the American Heart Association guidelines of 100 BPM beats per minute can cause incorrect or delayed diagnosis CHAPTER THREE Using the FORERUNNER ANALYSIS AND MONITORING Follow the instructions provided by the FORERUNNER voice and screen prompts When the FORERUNNER is turned on and detects that the defibrillation pads are connected properly it automatically begins analyzing ECG data to determine if a defibrillation shock is appropriate therapy If there is ECG interference the FORERUNNER provid
35. fibrillation pads to touch each other or to touch other ECG electrodes lead wires dressings transdermal patches etc Such con tact can cause electrical arcing and patient skin burns during defibrillation and may divert defibrillating current away from the heart A WARNING During defibrillation air pockets between the skin and defibrilla tion pads can cause patient skin burns To help prevent air pockets make sure defibrillation pads completely adhere to the skin Do not use dried out defibrillation pads A DANGER Possible explosion hazard if used in the presence of flammable anesthetics or concentrated oxygen A DANGER The FoRERUNNER has not been evaluated or approved for use in haz ardous locations as defined in the National Electrical Code standard Articles 500 503 In compliance with the IEC classification section 5 5 the FORERUNNER is not to be used in the presence of flammable substance air mixtures A WARNING Improper use can cause injury Use the FORERUNNER only as described in the User s Guide The FORERUNNER delivers electrical energy that can potentially cause death or injury if it is used or discharged improperly Do not dis charge with defibrillation pads together or open and exposed H CAUTION Hazardous electrical output This equipment is for use only by qualified personnel A CAUTION Aggressive or prolonged CPR to a patient with defibrillation pads attached can cause damage to the pads Replace the de
36. ibrillation pads firmly to the patient s chest The defibrillation pads are not making proper contact with the patient s bare chest Check the defibrillation pads on the patient and ensure that the pads adhere completely to the skin e fnecessary wipe moisture from the patient s chest and shave or clip excessive chest hair Replace the defibrillation pads if the prompt contin ues Voice and screen prompts instruct you to replace the defibrillation pads e The defibrillation pads cable or connector may be damaged The FORERUNNER has detected a possible short in the defibrillation pads or cable Replace the defibrillation pads 22 FORERUNNER CHAPTER THREE Using the FORERUNNER Error Condition Possible Cause Corrective Action Voice and screen prompts alert you that the ECG analysis has been interrupted e Patient motion Radio or electrical sources Motion around the patient in a dry environment where significant static electricity is present e Discontinue CPR do not touch the patient Attempt to eliminate patient motion if possible e Stop the patient transport vehicle if needed Check for and remove pos sible causes of radio and electrical interference Voice and screen prompts alert you that a shock was not deliv ered when you pressed the shock button The FORERUNNER will not deliver a shock within specifi cations if the patie
37. interval in minutes provided for CPR after each Shock sequence The FORERUNNER automatically pauses for CPR after the setup number of consecutive shocks It resumes analyzing automati cally at the end of the CPR Timeout or when the Resume Analyzing button is pressed by the user If CPR Timeout is set to co the automatic resume analyzing is disabled and the user MUST press the Resume Analyzing button to quit the pause for CPR 1 0 minute No Shock Advised NSA CPR Timeout 0 25 0 5 1 0 1 5 2 0 3 0 and oo NSA CPR Timeout is the interval in minutes pro vided for CPR immediately after a No Shock Advised condition See CS CPR Tim eout for Resume Analyzing details 0 minutes User s Guide 41 APPENDIX A FORERUNNER Options Resume Analysis ON or OFF ON activates a OFF Resume Analyzing buttonto ON if CPR Timeout is greater allow you to manually quit than 60 seconds the pause for CPR and resume ECG analysis OFF inhibits activation of the Resume Analyzing button NOTE ON is the only choice available if you select a CPR Timeout greater than 60 seconds 42 FORERUNNER APPENDIX A FORERUNNER Options FoRERUNNER Device History Information about the FORERUNNER automatically accumulates in its internal memory throughout the FORERUNNER s lifetime When you select the Device History option on the Setup card a screen displays the following information
38. kable rhythm is present and if so e arms the shock button You can deliver the defibrillation shock by pressing the flashing shock button 4 The FORERUNNER will not deliver a shock unless the shock button is pressed The FORERUNNER detects ECG signals and delivers the defibrillation shock using two self adhesive defibrillation pads The defibrillation pads cable and connector are supplied as one disposable assembly The FORERUNNER determines proper defibrillation pad contact by monitoring impedance between the two attached defibrillation pads T he FORERUNNER recognizes a shockable rhythm ventricular fibrillation or certain ventricular tachycardia based on an ECG analysis system The defibrillation shock is delivered using an impedance compensated biphasic waveform with a minimum of 130 Joules delivered to a 50 ohm load Power is provided by a disposable recyclable sealed lithium battery installed in the side of the FORERUNNER Voice prompts provide instructions and patient information and are reinforced by messages on the LCD screen Adjacent pushbuttons control the FORERUNNER An optional manual override button is available Model EM only for qualified users It overrides the ECG analysis system and permits the operator to manually charge the FORERUNNER and deliver a shock FORERUNNER CHAPTER ONE Introduction Optional PC data cards can record event information ECG voice and other audible activity Data stored
39. low battery or replace battery screen aself test error message remove and rein stall the existing battery and perform the BIT If the BIT passes the FORERUN NER is ready for use If the BIT fails install a new bat tery and repeat the BIT a second time If the BIT passes the FORERUNNER is ready to use If the BIT fails remove the FORERUN NER from service and con tact Customer Service 10 FORERUNNER CHAPTER TWO Putting the FORERUNNER into Service Status Indicator Condition Action Displays a solid red X X The FORERUNNER is not operable Do not use the FORERUNNER The solid red X can indicate a Training card is installed but unused for ten min utes aSetup card is installed the battery is missing or is completely depleted a self test detected a failure e Remove the Training or Setup card and reinsert the battery Remove and reinstall the battery to perform the BIT If the BIT passes the FORERUNNER is ready for use If the BIT fails install a new battery and repeat the BIT a second time If the BIT passes the FORERUNNER is ready to use If the BIT fails remove the ForeRunner from service and contact Customer Service Displays neither alternating hourglass nor flashing or solid red X Possible damage to the FORERUNNER Remove and reinstall the battery to perform a BIT If the BIT passes the FORERUNNER is ready for use If the
40. ltages and currents are present Do not open unit remove covers or attempt repair There are no user serviceable components in the FORERUNNER Refer servicing to qualified service personnel 28 FORERUNNER CHAPTER FOUR Maintaining the FORERUNNER CLEANING To clean the FORERUNNER observe the following guidelines The FORERUNNER should only be cleaned with the battery in place to keep fluids out of the PC data card slot and battery contact area Use a soft cloth Do not use abrasive materials cleaners or strong solvents such as acetone or acetone based cleaners Do not immerse the FORERUNNER in fluids Clean the FORERUNNER and the connector socket with appropriate cleaning agents listed below The connector socket includes a slot A to allow thorough cleaning Use only the following cleaning agents Isopropyl alcohol 7096 Solution Soapy water Chlorine bleach 30 ml l water Ammonia based cleaners Glutaraldehyde based cleaners Hydrogen peroxide A CAUTION Do not immerse any portion of the FORERUNNER in water or other fluids Do not allow fluids to enter the FORERUNNER Avoid spilling any fluids on the FORERUNNER or accessories Spilling fluids into the FORERUNNER may damage it or present a fire or shock hazard Do not autoclave or gas sterilize the FORERUNNER or accessories User s Guide 29 CHAPTER FOUR Maintaining the FORERUNNER The following checklist is provided for your reference AUTO
41. nance that you perform to assure that it is always ready for use SELF TESTS AND FORERUNNER MAINTENANCE The FORERUNNER automatically performs periodic self tests when a battery is installed and has enough power to perform the tests The FORERUNNER displays a message during these tests indicating that a self test is running If you press On Off S during a self test you discontinue the test The test is automatically rescheduled The results of the automatic self tests are displayed on the Status Indicator User s Guide 25 The Status Indicator displays information about self test results Alternates these shapes if the FORERUNNER passed the last self test Flashing red X accompanied by a chirping sound indicates a self test error occurred or that the battery is low or depleted Solid red X indicates the battery is completely depleted or a self test failure occurred X CHAPTER FOUR Maintaining the FORERUNNER If the FORERUNNER passed its last automatic self test the Status Indicator alternates between dark square and hourglass shapes A self test error storage of the FORERUNNER outside of the recommended temperature range or a low or partially depleted battery results in a flashing X displayed on the Status Indicator accompanied by a chirping sound A solid X 1s displayed if a Training or Setup Card is installed the battery is missing or fully depleted or a self test failure OCCUTS If the Status Indica
42. ned for a wide variety of field use conditions rough handling beyond specifications can result in damage to the unit See Environmental Specifications in Appendix B 66 FORERUNNER APPENDIX D Dangers Warnings and Cautions IN WARNING Aggressive or prolonged CPR to a patient with defibrillation pads attached can cause damage to the pads Replace the defibrillation pads if they become damaged during use IN WARNING Use of damaged equipment or accessories may cause the device to perform improperly and or patient or user injury IN WARNING CPR rates above the American Heart Association guidelines of 100 BPM beats per minute can cause incorrect or delayed diagnosis Possible Electrical Interference with ECG monitoring A WARNING Radio frequency RF interference from RF devices such as cel lular phones and two way radios can cause improper FORERUNNER operation In accordance with IEC standard 801 3 a distance of 2 meters 6 feet between RF devices and the FORERUNNER is recommended DEFIBRILLATION Possible Shock Hazard A WARNING Defibrillation current can cause operator or bystander injury Do not touch the patient during defibrillation Do not touch equipment connected to or metal objects in contact with the patient during defibrillation Disconnect other electrical equipment from the patient before defibrillating Disconnect the FORERUNNER from the patient prior to use of other defibrillators Possible Patient Safety
43. nt imped ance is out of the specified range Check the defibrillation pads for proper placement Check the defibrillation pads connector Press the defibrillation pads firmly to the patient s chest Replace the defibrillation pads if necessary User s Guide 23 CHAPTER THREE Using the FORERUNNER CONTINUED USE The FORERUNNER provides a feature called Continued Use to preserve the data recorded during an emergency event when you change a battery or turn the FORERUNNER off briefly If the FORERUNNER is turned off and then on again during an emergency event data on the card and in Summary Event Review is preserved and new data appended if 1 The FORERUNNER is turned off for less than 5 minutes or 2 Thebattery is removed for less than 30 seconds Data preservation is not assured if the battery is removed for more than 30 seconds Continued Use also allows you to quickly resume patient care when changing a battery during use When a Continued Use occurs the Battery Insertion Test is not done unless the status indicator shows the device is not ready for use Then the test is run to attempt to clear any error conditions 24 FORERUNNER Self Tests and FoRERUNNER Maintenance Maintenance Schedule e Cleaning e Automated Defibrillators Operator s Check List CHAPTER FOUR Maintaining the FORERUNNER his chapter describes FORERUNNER automatic self tests and the occasional mainte
44. ocket LED illuminates and flashes to indicate the socket location and is covered when the defibrillation pad con nector is properly inserted The shock button illuminates flashes when the defibrillator is armed Audio Speaker Beeper An audio speaker provides voice prompts Volume of voice prompts is adjustable using the Setup card The beeper chirps as an alert when a self test has failed standby mode and generates various warning tones during normal use Status Indicator A Status Indicator LCD displays the results of the last self test Defibrillation Pads Category Specification Defibrillation Pads Cable and Connector Defibrillation Pad Requirements Disposable and self adhesive Defibrillation pads have a nominal active surface area of 100 cm each and are provided in a sealed package with an integrated 122 cm 48 inch typical long cable and connector Use only Heartstream defibrillation pads with the FORERUNNER Place the pads in standard anterior anterior position User s Guide 51 APPENDIX B Specifications PC Data Cards Training and Setup Cards Options All FORERUNNER models come equipped with built in hardware and software that enable the defibrillator to perform additional medical control setup and training functions when used with optional Heartstream Setup Training and PC data cards The information stored on the data cards can be reviewed
45. onds after charging if a shock is not delivered e manually by pressing the manual override button the FORERUNNER On Off button is pressed and the FORERUNNER is turned off the defibrillator pads are removed from the patient or the pads connector is disconnected from the FORERUNNER User s Guide 47 APPENDIX B Specifications Category Specification Shock Delivery Via defibrillation pads placed in the anterior anterior Lead II position Patient Analysis System Category Specification Patient Analysis Evaluates defibrillation pads impedance for proper defibrilla tion pad contact and evaluates patient ECG and signal quality to determine if a shock is appropriate Protocols Follows pre configured settings to match your program s proto cols These settings can be modified using the setup options Shockable Rhythms VF and certain VT rhythms including ventricular flutter and polymorphic VT IN WARNING Some very low amplitude or low frequency rhythms may not be interpreted as shockable VF rhythms Also some VT rhythms may not be inter preted as shockable rhythms 46 FORERUNNER APPENDIX B Specifications Patient Analysis System Performance Rhythm Class ECG Test Sample Size Specification non shockable rhythms Shockable Rhythm VF 300 FORERUNNER meets the AAMI DF39 requirement and AHA recommendation of
46. option Setup options are saved automatically in the FORERUNNER when you quit setup User s Guide 39 APPENDIX A FORERUNNER Options General Setup Options Menu item Options Factory Settings Prompts Speaker Volume Short or Long Long voice prompts contain more descriptive information Short voice prompts are intended for use by more experienced responders 1 8 Eight possible settings 8 is full volume Long ECG Record Std or Low Std records ECG data on PC data cards at 200 data samples per sec ond low at 100 samples per second Low resolution recording provides a longer ECG recording Std resolu tion provides research qual ity ECG recording Std ECG Displayed Model E only Yes or no ECG is displayed on the screen Yes ECG display on ECG is always displayed on Model EM Go to CPR Protocol Displays options to customize the CPR and Shock sequence See CPR Protocol Setup Options that follow Go to Device History Displays Device History See Device History information that follows 40 FORERUNNER CPR Protocol Setup Options APPENDIX A FORERUNNER Options Menu item Options Factory Settings Shocks 1 2 or 3 Number of shocks delivered in a sequence before the FORERUNNER will pause for CPR 3 shocks Consecutive Shock CS CPR Timeout 0 0 5 1 0 1 5 2 0 2 5 3 0 or CS CPR Timeout is the
47. or metal objects in contact with the patient during defibrillation Disconnect other electrical equipment from the patient before defibrillating Disconnect the FORERUNNER from the patient prior to use of other defibrillators Press the shock button A to deliver the shock The FORERUNNER requires five seconds of interference free ECG data to determine if a shock is appropriate therapy When the FORERUNNER has analyzed the ECG data and deter mined that a defibrillating shock is appropriate audible warn ings and screen prompts tell you that a shock is advised and to stand clear of the patient While the FORERUNNER charges it continues to monitor ECG data In the event a patient s heart rhythm spontaneously returns to one for which shock is not advised the FORERUNNER disarms Voice and display prompts advise you what action to take Note that when the FORERUNNER is fully charged you can disarm it at any time by pressing the On Off button 7 to turn off the FORERUNNER The FORERUNNER provides four ways of prompting a shock Press the shock button 7 when any of these occur avoice prompt instructs you to deliver a shock the shock button flashes you hear a steady tone you see a screen prompt The FORERUNNER will not automatically deliver a shock User s Guide 17 CHAPTER THREE Using the FORERUNNER After you press the shock button D a voice prompt confirms that the shock was delivered and
48. ossary of Symbols T his appendix includes a glossary of symbols User s Guide 59 Icon APPENDIX C Glossary of Symbols FORERUNNER SYMBOLS Description On Off button 9 9 o Turns the FORERUNNER on or off Shock button E Delivers shock to patient when the FORERUNNER is charged Manual override button e Initiates manual override delivery of shock Contrast up button Increases the screen contrast or performs the function indicated on the screen Contrast down button e Decreases the screen contrast or performs the function indicated on the screen Defibrillation protection l F Defibrillation protected type BF patient connection High voltage present Refer to operating instructions 60 FORERUNNER SCREEN SYMBOLS APPENDIX C Glossary of Symbols Icon Description HR XX Heart Rate HR Heart Rate not available Number of shocks delivered x 4 XX XX Elapsed time since the FORERUNNER was turned on A Temperature The recommended standby storage temperature range has been exceeded since the last BIT was performed Check to assure that the FORERUNNER is stored within the range specified in Appendix B A Setup The setup options configuration has been lost from memory The FORERUNNER is using the default factory settings To clear this message use the Setup card described in Appendix A If
49. other ECG electrodes lead wires dressings transdermal patches etc Such con tact can cause electrical arcing and patient skin burns during defibrillation and may divert defibrillating current away from the heart A WARNING During defibrillation air pockets between the skin and defibrilla tion pads can cause patient skin burns To help prevent air pockets make sure self adhesive defibrillation pads completely adhere to the skin Do not use dried out defibrillation pads MONITORING Possible Misinterpretation of ECG Recordings A CAUTION The LCD screen is intended only for basic ECG rhythm identifica tion The frequency response of the monitor screen is not intended to provide the resolution required for diagnostic and ST segment interpretation MAINTENANCE Possible Fire or Shock Hazard A CAUTION Electrical shock hazard Dangerous high voltages and currents are present Do not open unit remove covers or attempt repair There are no user serviceable components in the FORERUNNER Refer servicing to qualified service personnel Possible Improper Device Performance IN CAUTION Improper maintenance can cause the FORERUNNER not to function Maintain the FORERUNNER only as described in this User s Guide or as instructed by your medical director FORERUNNER INDEX A accessories available to order 57 maintaining 27 adjust contrast during BIT 9 AED overview 1 analysis requirements for shock decision 17 applying d
50. pause for CPR The FORERUNNER can be programmed however to change both the number of consecutive shocks before a pause and the duration of the CS pause period see Appendix A for instructions NSA Pause A pause for CPR following a No Shock Advised prompt is also available As with the CS pause the duration of the NSA pause is programmable 18 FORERUNNER CHAPTER THREE Using the FORERUNNER RESUME ANALYZING gt v If you use the MODEL E or MopEL EM you can see the patient s ECG trace on the screen Resume Analysis During Pause All FORERUNNER models include an option that lets you quit the pause for CPR to manually resume ECG analysis You can implement this option when you set up the FORERUNNER See Appendix A for setup instructions If this option is imple mented the screen includes a text prompt opposite a contrast button during a pause for CPR To quit the pause for CPR and resume ECG analysis press the contrast down button v At the end of the pause for CPR or when you resume analysis the FORERUNNER advises you to stop moving the patient so it can perform analysis on the ECG data without interference Voice and screen prompts guide you through additional shock sequences if appropriate MANUAL DELIVERY OF DEFIBRILLATION SHOCK AN IN CAUTION The FoRERUNNER manual override button is intended for use only by qualified operators who have been trained in rhythm recognition
51. resence of detectable pulse DANGERS WARNINGS AND CAUTIONS This manual contains a list of danger warning and caution messages in Appendix D These terms are used throughout this User s Guide or on the FORERUNNER Please familiarize yourself with their definitions and significance FORERUNNER How to Put the FORERUNNER into Service Battery Installation and the Battery Insertion Test Q Status Indicator and Automatic Self Tests CHAPTER TWO Putting the FORERUNNER into Service ou need three items to put the FORERUNNER into Y service the FORERUNNER its battery and the package containing the defibrillation pads with attached cable and connector When you put the FORERUNNER into service however it is recommended that you carry a spare package of defibrillation pads a spare battery and a spare PC data card if the FORERUNNER uses this option How TO PUT THE FORERUNNER INTO SERVICE The FORERUNNER is shipped with standard factory settings and without a PC data card The settings should be reviewed against your program s protocol and changed as needed Failure to configure settings correctly may adversely affect use of the FORERUNNER Installing a PC data card is optional User s Guide CHAPTER TWO Putting the FORERUNNER into Service To put the FORERUNNER into service using the standard factory settings and no PC data card For information about setup options 1 Insert the battery and perform the Batt
52. s Indicator 11 26 device history 43 DISARM 20 disarming the FORERUNNER 17 User s Guide 69 display the Event Review how to 33 display ECG specifications 50 display LCD adjusting contrast during BIT 9 E ECG analysis during CPR 19 data quality 16 67 display option Model E only 40 misinterpretation 67 68 monitoring and analysis 16 patient analysis system 48 49 ECG display specification 50 elapsed time of emergency 18 34 35 electrical interference hazard 67 electrode pads See defibrillation pads electrode placement 14 environmental specifications 46 error conditions and corrective actions 21 22 Event Review about 34 displaying information 33 Full 35 Summary 35 explosion hazard 66 F factory settings 61 for setup options 40 failed self test and the Status Indicator 25 causes and corrective actions 10 failure 10 21 26 FORERUNNER Model E capabilities 37 options 40 FORERUNNER Model EM and manual override mode 19 INDEX capabilities 37 options 40 43 FORERUNNER Model S capabilities 37 options 40 43 Full Event Review 35 H heart rate display option 37 displayed on screen 61 heart rhythms shockable 2 48 how to configure options 38 how to deliver shock 17 how to display event review information 33 how to install the battery 6 how to put the FORERUNNER into service 5 how to use manual override mode Model EM only 19 HR in screen 61 impedance error conditions and correc
53. se Observe Check the Status Indicator Verify that you see alter nating dark and hourglass shapes that indicate the FORERUNNER is ready to use Ensure that all supplies acces sories and spares are present undamaged and have not passed their expiration dates Take Action If you see any condition other than the alternating dark square and hourglass shapes such as a constant dark shape a flashing red X or a solid red X do the following If there is no low battery or replace battery screen message remove and reinstall the exist ing battery and perform the BIT as described in Chapter 2 Putting the FORERUNNER into Service If the BIT passes and the Status Indicator alternates dark and hourglass shapes return the FORERUNNER to service If the BIT fails install a new battery and repeat the BIT a second time If the BIT passes return the FORERUNNER to service If the BIT fails remove the FORERUNNER from service and contact Customer Service Do not use damaged or expired supplies accessories or spares Replace supplies accessories and spares as needed Do not leave electrodes con nected to the FORERUNNER when not in use User s Guide 27 CHAPTER FOUR Maintaining the FORERUNNER Frequency Observe Take Action Weekly and after each use Ensure the exterior of the Perform a BIT if the FORERUNNER and the connec FORERUNNER is damaged or tor socket are free of cracks subjected
54. se Bandwidth Nondiagnostic rhythm monitor 1 Hz to 20 Hz 3 dB nominal Sensitivity 1 16 cm mV nominal Heart Rate Displays a range of 30 to 300 beats per minute updated each analysis period Heart rate is displayed only during monitoring mode and if ECG is displayed Battery Pack Category Specification Battery 18 VDC 1300 mAH lithium Disposable recyclable long life primary cells Capacity A new battery typically will provide 100 shocks or 5 hours of operating time or 10 hours of training time at 25 C Shelf Life Typically 5 years from date of manufacture when stored at standby environmental conditions in original unopened packaging Standby Life Typically more than one 1 year when stored under standby environmental conditions 1 battery insert test and no uses or training Low Battery Detection Defibrillator detects low battery condition during daily periodic self tests Replace the battery when the Status Indicator shows a solid or flashing red X 50 FORERUNNER Controls and Indicators APPENDIX B Specifications Category Specification Main LCD screen A high resolution backlit LCD screen displays ECG MODELS E and EM and informational instructional text messages on all models Controls On Off button 75 Shock button Manual override button MODEL EM Only Contrast up button Contrast down button LED Indicators Connector s
55. t s heart rhythm and illuminates the shock button if analysis determines that a shock is appropriate If you decide against delivering the shock after the FORERUNNER Model EM is charged press the manual over ride button to disarm and return to semi automatic oper ation The FORERUNNER automatically disarms and returns to semi automatic operation after 30 seconds if the shock button Gy has not been pressed 20 FORERUNNER CHAPTER THREE Using the FORERUNNER ERROR CONDITIONS POSSIBLE CAUSES AND CORRECTIVE ACTIONS If the FORERUNNER detects an error condition or system fault during use it provides a voice or display prompt or a combination of both These are described below Error Condition Possible Cause Corrective Action A screen prompt alerts you that the FORERUNNER is not ready for use or that a self test failed The Status Indicator dis plays a flashing or solid red x X The FORERUNNER performs self tests when you turn it on and while it is in use A test revealed a failure or error Unplug the pads connector from the FORERUNNER Remove and reinstall the bat tery to perform a BIT If the BIT passes the FORERUNNER is ready for use If the BIT fails install a new battery and repeat the BIT If the BIT passes the FORERUNNER is ready for use If the BIT fails remove the FORERUNNER from service and contact Cus tomer Service NOTE You can stop the BIT and resume use of the
56. ted with three shocks or fewer The average number of shocks per VF episode was 1 3 0 7 The average time from AED power on and pads attached to first defibrillation was 25 23 seconds At the time of patient transfer an organized rhythm was present in 65 of patients presenting with VF Asystole was the result in 2596 of patients and VF was in progress in 1096 of patients at the time of transfer Conclusions Low energy impedance compensating biphasic waveforms terminate long duration VF at high rates in out of hospital cardiac arrest and provide defibrillation rates exceeding those previously published with high energy shocks Use of this waveform allows AED device characteristics consistent with widespread AED deployment and early defibrillation Gliner BE et al Treatment of out of hospital cardiac arrest with a low energy impedance compensating biphasic waveform automatic external defibrillator Biomedical Instrumentation amp Technology 1998 32 xx xx User s Guide 55 APPENDIX B Specifications AMERICAN HEART ASSOCIATION DEFIBRILLATION STATEMENT A recent April 1998 scientific statement by the American Heart Association determined that the FORERUNNER s waveform is safe acceptable and clinically effective In its conclusions the AHA gave the use of the low energy impedance compensating biphasic waveform a Class IIb recommendation making it the only defibrillation waveform to date to receive an AHA class re
57. the message persists after you use the Setup card call Customer Ser vice A REV XXXX XXXX The REV number identifies the version of software and hard ware used in your FORERUNNER User s Guide 61 Icon APPENDIX C Glossary of Symbols PC CARD SYMBOLS Meaning Training card The Training card includes several simulated scenarios that guide students through several emergency events Setup card The Setup card allows you to configure options to match your program s protocol Event Review card B Full ECG card BU Event Review recording capability Event Review with ECG recording capability Voice and ECG card Event Review with ECG and voice recording capability 62 FORERUNNER APPENDIX C Glossary of Symbols Icon Meaning Insert Insert the data card into the FORERUNNER with this side up For use until The PC data card contains a battery Do not use the PC data card INIA ILI AMT 123456789 E FOR USE UNTIL 1998 02 after the date indicated because the battery may be low or depleted User s Guide 63 APPENDIX C Glossary of Symbols BATTERY SYMBOLS Icon Meaning Do not crush the battery IN P d KY Do not expose the battery to high heat or open flames Do not incinerate or Do not mutilate the battery or open the battery case 1 Install the ba
58. tive actions 23 improper device performance hazard 68 indications and contraindications 3 information storage and retrieval 31 Install Before 64 installing a data card 32 installing battery 6 installing Setup card 38 interference 16 during pause for CPR 18 electrical 16 23 67 patient motion 23 proper distance from RF sources 16 radio frequency 16 67 L LCD screen adjust contrast 9 low battery and Status Indicator 10 26 maintaining the connector socket 27 the defibrillation pads 27 the FORERUNNER 27 maintenance after each use 27 28 daily 27 weekly 27 mannequin adaptor accessory for training 44 manual delivery of defibrillation shock 19 MANUAL OVERRIDE 20 manual override disarming 20 testing 9 manual override mode Model EM only 19 mechanical damage 27 Model E options 40 Model EM options 40 Model S options 41 monitoring voice prompts suppressed 16 new use 24 no shock advised 16 number of shocks delivered Full Event Review 35 ina single use 34 screen symbol 61 Summary Event Review 35 70 FORERUNNER 0 On Off button test 9 to discontinue self tests 25 to interrupt the BIT 7 option FORERUNNER Model E 37 FORERUNNER Model EM 37 FORERUNNER Model S 37 hide or display ECG trace Model E only 40 manual override Model EM only 19 37 pause for CPR 18 41 resume analyzing 19 42 setup options 40 speaker volume 40 training 44 P pacemaker use with 16 67 pad placement 14 patient anal
59. tor displays anything other than the alternating hourglass shapes such as a constant dark shape or a flashing or solid X remove the FORERUNNER from service If there is no low battery or replace battery screen message remove and reinstall the existing battery and perform the BIT as described in Chapter 2 Putting the FORERUNNER into Service If the BIT passes and the Status Indicator alternates dark and hourglass shapes return the FORERUNNER to service If the BIT fails install a new battery and repeat the BIT a second time If the BIT passes return the FORERUNNER to service If the BIT fails remove the FORERUNNER from service and contact Customer Service The FORERUNNER is designed to be transported stored and operated within the environmental conditions specified in Appendix B FORERUNNER performance may be decreased outside of these conditions Self Tests During Use The FORERUNNER performs a Power On Self Test POST each time you turn it on Self tests continue to monitor the hardware and software systems and battery while the FORERUNNER is in use 26 FORERUNNER MAINTENANCE SCHEDULE CHAPTER FOUR Maintaining the FORERUNNER The following table provides suggested frequencies for mainte nance Different frequency intervals may be appropriate depend ing upon the environment in which the FORERUNNER is used and is at the discretion of your program s medical director Frequency Daily and after each u
60. ttery in the FORERUNNER prior to the date iced indicated Do not install the battery after this date Heavy metal substances Do not dispose of improperly X Collect and recycle separately from household wastes Li 64 FORERUNNER General 9 Defibrillation Monitoring Maintenance APPENDIX D Dangers Warnings and Cautions his Appendix includes the list of danger warning and caution messages CAUTION Conditions hazards or unsafe practices that can result in minor personal injury damage to the FORERUNNER or loss of data WARNING Conditions hazards or unsafe practices that can result in serious personal injury or death DANGER Immediate hazards which will result in serious personal injury or death User s Guide 65 APPENDIX D Dangers Warnings and Cautions GENERAL Possible Shock or Fire Hazard or Explosion IN DANGER Possible explosion hazard if used in the presence of flammable anesthetics or concentrated oxygen A WARNING Improper use can cause injury Use the FORERUNNER only as described in the User s Guide The FoRERUNNER delivers electrical energy that can potentially cause death or injury if it is used or discharged improperly Do not dis charge with defibrillation pads together or open and exposed A CAUTION Hazardous electrical output This equipment is for use only by qualified personnel A CAUTION Do not immerse any portion of the FORERUNNER in water
61. using optional software Category Specification Event Review Card Provides the FORERUNNER with Event Review capability and 15 minutes of ECG data collection This card incorporates a real time clock which provides a means for synchronizing the EMS system time with the recorded code events Full ECG Card Provides the FORERUNNER with Event Review capability as well as providing a maximum of 30 minutes of ECG data collection A real time clock is also incorporated in this card Voice and ECG Card Same as Full ECG Card with the added capability of digitally recording a maximum of 26 minutes per use near area sounds and voices Sound recording is synchronized with ECG and event data Training Card When the Training card is installed the FORERUNNER operates in a special training mode which provides several training sce narios Use of the Training card and training scenarios are described in the Training card user s guide Setup Card Provides the system administrator with a means to tailor the FORERUNNER to your program s protocol 52 FORERUNNER APPENDIX B Specifications Waveform Specifications The FORERUNNER defibrillator delivers patient compensated biphasic truncated exponential waveforms with a nominal of 150 Joules minimum of 130 Joules delivered to a 50 ohm load Phase 1 Duration H Phase 2 Duration gt BITE Interphase Delay D Oo m S
62. ysis system performance 49 patient analysis system specifications 48 patient safety hazard 67 pause for CPR 18 configuring options 40 duration 41 interrupting 19 PC data card and accessory software 31 categories of 52 compatible versions 32 installation 32 maintenance 28 symbols 62 uses 35 verification during BIT 8 periodic self test 10 POST Power On Self Test 26 power INDEX battery module specifications 50 See On Off button preparing the patient 14 prompts setup options 40 protocols for CPR customizing 41 radio signal interference 16 23 67 recommended distances 16 removing data card 32 replaceable parts 57 resume analysis during CPR 19 setup option 42 RESUME ANALYZING 19 configuring option 42 RF interference 16 23 67 S screen adjust contrast 9 self test adjust screen contrast 9 BIT 7 connector socket LED 9 discontinue and reschedule 25 failed 21 25 interpreting results 10 21 manual override button 9 On Off button 9 results 10 26 shock button 9 shock button LED 9 speakers 9 self test failure and Status Indicator 11 semi automatic delivery of defibrillating shock 17 service and replaceable parts 57 servicing the FORERUNNER 57 setup 61 Setup card affecting Status Indicator 10 installing and using 38 setup options factory settings 40 61 general 40 43 shock CPR protocol 41 delivering 17 disarming in manual override mode Model EM 20 disarming in semi automatic

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